Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136019
Status:
COMPLETED
Last Update Posted:
2014-09-22
First Post:
2005-08-24
Brief Title:
SPM 927 400mgDay and 600mgDay as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
A Multicenter Double-blind Randomized Placebo-controlled Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 400mgDay and 600mgDay as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with partial seizures and are taking up to 3 medications for this medical condition will take part in a research study at approximately 85 different locations in the United States
The purpose of the study is to evaluate the effectiveness safety and tolerability of consistent dosages of a study drug lacosamide SPM 927 taken orally twice a day for about five months
Each patient who qualifies and chooses to participate in the study will receive placebo inactive drug or gradually increasing doses of lacosamide up to the target dose of 400mgday or 600mgday The target dose or placebo will be maintained for 12 weeks
The study clinic visits will include a medical history and physical exam electrocardiogram ECG blood and urine sample collection and completion of a seizure diary
Patients who complete the study may enroll in an extension trial and receive active study drug
The purpose of the study is to evaluate the effectiveness safety and tolerability of consistent dosages of a study drug lacosamide SPM 927 taken orally twice a day for about five months
Each patient who qualifies and chooses to participate in the study will receive placebo inactive drug or gradually increasing doses of lacosamide up to the target dose of 400mgday or 600mgday The target dose or placebo will be maintained for 12 weeks
The study clinic visits will include a medical history and physical exam electrocardiogram ECG blood and urine sample collection and completion of a seizure diary
Patients who complete the study may enroll in an extension trial and receive active study drug
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None